MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/18 HOLE/370MM/RIGHT; APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR

Model Number 02.124.418

Device Problem Break (1069)

Patient Problems Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This information is unknown.It is unknown when plate broke.Additional procodes: hrs, hwc.Lot number is unknown.Date of implantation is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Product was not returned and no lot number was provided.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on (b)(6) 2018, the patient underwent hardware removal of a variable angle (va) plate, eleven (11) va locking screws, four (4) cortex screws, and one (1) 6.5 or 7.3mm cannulated screw.It is not known when the variable angle (va) distal femur plate was implanted.The patient apparently stepped off a curb and the plate broke at the sixth most distal combi-hole due to non-union.Non-union of the mid-shaft and distal femur was confirmed by the surgeon after the entire implant system was removed.Surgeon reported to the sales consultant that it was a non-union rather than the plate's fault.The patient is scheduled for revision to a retrograde nail and distal femur plate on (b)(6) 2018.Explantation surgery was successful.It is unknown if there was a surgical delay.No patient outcome was reported.Concomitant devices: va locking screws (part: unknown, lot: unknown, quantity: 11); cortex screws (part: unknown, lot: unknown, quantity: 4); cannulated screw (part: unknown, lot: unknown, quantity: 1).This report is for a 4.5mm va-lcp curved condylar plate/18 hole/370mm/right.This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/18 HOLE/370MM/RIGHT
• Type of Device: APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7710128
• MDR Text Key: 114694438
• Report Number: 2939274-2018-53016
• Device Sequence Number: 1
• Product Code: JDO
• UDI-Device Identifier: 10886982042972
• UDI-Public: (01)10886982042972
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.124.418
• Device Catalogue Number: 02.124.418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2018
• Initial Date FDA Received: 07/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SEE DESCRIPTION, THERAPY DATE: UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 91